Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
665 participants
INTERVENTIONAL
2014-10-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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ALD403 Dose Level 1
ALD403 Dose Level 1 (IV)
ALD403
ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
ALD403
ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
ALD403
ALD403 Dose Level 4
ALD403 Dose Level 4 (IV)
ALD403
Placebo
Placebo (IV)
Placebo
Interventions
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ALD403
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
* Headache eDiary was completed on at least 22 of the 28 days prior to randomization
Exclusion Criteria
* Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening.
* History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
* Unable to differentiate migraine from other headaches
* Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
* Have any clinically significant concurrent medical condition
* Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
* Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
18 Years
55 Years
ALL
No
Sponsors
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Alder Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff TL Smith, MD
Role: STUDY_DIRECTOR
Alder Biopharmaceuticals, Inc.
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Encino, California, United States
Reserach Site
Long Beach, California, United States
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Los Angeles, California, United States
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Oakland, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Ventura, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Stamford, Connecticut, United States
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Waterbury, Connecticut, United States
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Gainesville, Florida, United States
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Hallandale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Illinois, United States
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Normal, Illinois, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Watertown, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Amherst, New York, United States
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Brooklyn, New York, United States
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Endwell, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Cary, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Orem, Utah, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Sydney, New South Wales, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Auckland, , New Zealand
Research Site
Christchurch, , New Zealand
Research Site
Hamilton, , New Zealand
Countries
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References
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Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.
Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.
Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
Related Links
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Related Info
Other Identifiers
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ALD403-CLIN-005
Identifier Type: -
Identifier Source: org_study_id
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